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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-A00754-39 | Other Identifier | 2022-A00754-39 |
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The goal of this clinical trial is to evaluate in real life, in patients with Hereditary Hemorrhagic Telangiectasia (HHT), the tolerance of the strategy of use of anticoagulant and/or antiplatelet, by comparing a new exposure period (first trimester of treatment) to a period of reference non-exposure (last trimester before start of treatment).
Currently there are no recommendations on the use of anticoagulant and/or antiplatelet treatment in patients with Rendu-Osler Disease.
The main question this study aims to answer is:
• to better determine which anticoagulant and/or antiplatelet therapy are best tolerated or if they are equivalent in Rendu-Osler disease because this type of treatment is often used in urgent and/or vital situations.
Participants will have a 2-year follow-up with biological monitoring of ferritin and hemoglobin level and ESS (Epistaxis Severity Score) and QoL-HHT (Quality of Life Hereditary Hemorrhagic Telangiectasia) questionnaires.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort study | Other | a single arm, the anticoagulant and/or antiplatelet treatment is not conditioned by the study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| monitoring the use of anticoagulant and/or antiplatelet therapy in patients with osler rendering disease | Other | Monitoring:
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of transfusions and/or intravenous iron | Number of transfusions and/or intravenous iron before (3 months) and within 3 months after exposure to anticoagulants and/or antiplatelet in patients with Rendu-Osler disease. | 3 months after exposure to anticoagulants and/or antiplatelet |
| Measure | Description | Time Frame |
|---|---|---|
| Biological parameters | Evolution of ferritin levels. | 3 months after exposure to anticoagulants and/or antiplatelet |
| Biological parameters | Evolution of hemoglobin levels. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | 334.73.754.963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Vincent GROBOST | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Recruiting | Angers | France |
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cohort study
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| 3 months after exposure to anticoagulants and/or antiplatelet |
| Bleeding | Onset of digestive bleeding and/or occurrence of a new hemorrhagic accident or major hemorrhagic event and/or hospitalisation for hemorrhage. | 3 months after exposure to anticoagulants and/or antiplatelet |
| Anticoagulant and/or antiplatelet treatment | Frequency of continuation and/or modification and/or cessation of treatment if indication maintained. | week 104 after patient inclusion |
| Thrombotic accident | Frequency of occurrence of a new arterial and/or venous thrombotic accident and/or death | week 104 after patient inclusion |
| Epistaxis | Evolution of epistaxis severity via ESS score | week 12, 52 and 104 after patient inclusion |
| Evaluation of Quality of life | Quality of life assessment via QoL-HHT questionnaire | week 6, 12, 52 and 104 after patient inclusion |
| CHU de Bordeaux | Recruiting | Bordeaux | France |
|
| Hôpital Ambroise Paré | Not yet recruiting | Boulogne-Billancourt | France |
|
| CHU de Caen Normandie | Recruiting | Caen | France |
|
| CHU clermont-ferrand | Recruiting | Clermont-Ferrand | France |
|
| CHU de Dijon | Recruiting | Dijon | France |
|
| CHRU de Lille | Not yet recruiting | Lille | France |
|
| Hospices Civiles de Lyon | Recruiting | Lyon | France |
|
| Assistance Publique - Hôpitaux de Marseille | Not yet recruiting | Marseille | France |
|
| CHU de Montpellier | Recruiting | Montpellier | France |
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| CHU de Nancy | Recruiting | Nancy | France |
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| CHU de Nantes | Recruiting | Nantes | France |
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| CHU de Nice | Recruiting | Nice | France |
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| AP-HP - Hôpital Ténon | Recruiting | Paris | France |
|
| CHU de Poitiers | Not yet recruiting | Poitiers | France |
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| CHU de Rennes | Recruiting | Rennes | France |
|
| CHRU de Strasbourg | Recruiting | Strasbourg | France |
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| CHU de Toulouse | Not yet recruiting | Toulouse | France |
|
| ID | Term |
|---|---|
| D013683 | Telangiectasia, Hereditary Hemorrhagic |
| D004844 | Epistaxis |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D013684 | Telangiectasis |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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